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Transcutaneous Tibial Nerve Stimulation for Idiopathic Overactive Bladder

Primary Purpose

Overactive Bladder, Overactive Bladder Syndrome, Overactive Detrusor

Status
Not yet recruiting
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Bladder training
Transcutaneous tibial nerve stimulation
Sponsored by
Ege University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Overactive Bladder focused on measuring tibial nerve stimulation

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria: Overactive Bladder Questionnaire Validation Study questionnaire 8 scores higher than 11. Post voiding residue levels less than 100 ml. Women aged between 18-70 Exclusion Criteria: Prior history of pelvic surgery Pelvic organ prolapsus of grade 2 or more. Current urinary tract infection

Sites / Locations

  • Ege University School of Medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

Transcutaneous tibial nerve stimulation plus bladder training

Bladder training

Arm Description

Patients will receive transcutaneous tibial nerve stimulation for 30 minutes, twice a week, for 6 weeks. Application will be done in an outpatient setting, using disposable surface electrodes.

patients will receive only the routine education program that is given to every patient with idiopathic overactive bladder syndrome. This includes education about the anatomy of the urinary system, patient motivation, and frequent bathroom visits in order to avoid incontinence with gradual increase between each visit to the bathroom.

Outcomes

Primary Outcome Measures

Urination frequency
The frequency of urination will be recorded by using a bladder diary. Urination frequency will be questioned before and after the study period.
Severity of overactive bladder symptoms. Overactive Bladder Questionnaire Validation Study questionnaire
This questionnaire assesses the severity of overactive bladder symptoms in 8 items. Each item is scored from 0 to 5. Higher scores denote worse symptom severity. Maximum score is 40. A score over 11 denotes presence of overactive bladder symptoms. Questionnaire will be answered before and after the treatment period.

Secondary Outcome Measures

Quality of life. King's quality of life questionnaire
This questionnaire includes a total of 19 questions assessing general quality of life and also questions related to urinary symptoms. Maximum score is 100 and higher scores denote lower levels of quality of life. Questionnaire will be answered before and after the treatment period.
Level of satisfaction with the treatment. Visual analog scale
After the completion of the study period, patients will be asked to assess their levels of satisfaction with the treatment they received on a visual analog scale.
Incontinence impact questionnaire-7.
This 7 item questionnaire assesses the impact of urinary incontinence on the patients' daily lives. Maximum score is 100. Higher scores denote worse outcomes. Questionnaire will be answered before and after the treatment period.

Full Information

First Posted
July 28, 2023
Last Updated
September 6, 2023
Sponsor
Ege University
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1. Study Identification

Unique Protocol Identification Number
NCT05977634
Brief Title
Transcutaneous Tibial Nerve Stimulation for Idiopathic Overactive Bladder
Official Title
The Efficacy of Transcutaneous Tibial Nerve Stimulation on Symptoms of Overactive Bladder and Quality of Life in Women With Idiopathic Overactive Bladder
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
September 30, 2023 (Anticipated)
Primary Completion Date
July 30, 2026 (Anticipated)
Study Completion Date
August 30, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ege University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
This study was designed to assess the efficacy of trans cutaneous tibial nerve stimulation on symptoms of overactive bladder in women with idiopathic overactive bladder
Detailed Description
Idiopathic overactive bladder is defined the presence of a sense of urgency with or without accompanying urinary incontinence without an organic pathology or urinary infection. Its prevalence was reported to be between 7.7 to 31 % in women. In this prospective randomized controlled study, we aim to assess the efficacy of trans cutaneous tibial nerve stimulation on symptoms of overactive bladder in women with idiopathic overactive bladder.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Overactive Bladder, Overactive Bladder Syndrome, Overactive Detrusor
Keywords
tibial nerve stimulation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Masking Description
Outcome assessor and investigator that assesses the patients will be blind to the study groups
Allocation
Randomized
Enrollment
26 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Transcutaneous tibial nerve stimulation plus bladder training
Arm Type
Experimental
Arm Description
Patients will receive transcutaneous tibial nerve stimulation for 30 minutes, twice a week, for 6 weeks. Application will be done in an outpatient setting, using disposable surface electrodes.
Arm Title
Bladder training
Arm Type
Other
Arm Description
patients will receive only the routine education program that is given to every patient with idiopathic overactive bladder syndrome. This includes education about the anatomy of the urinary system, patient motivation, and frequent bathroom visits in order to avoid incontinence with gradual increase between each visit to the bathroom.
Intervention Type
Behavioral
Intervention Name(s)
Bladder training
Intervention Description
Bladder training has 4 components, educating the patient about anatomy, fluid intake control, pelvic floor muscle contractions and increasing the interval between visits to the bathroom
Intervention Type
Device
Intervention Name(s)
Transcutaneous tibial nerve stimulation
Intervention Description
A combined electrotherapy device capable of applying transcutaneous electrical nerve stimulation will be used. Each session will take 30 minutes. Patient will visit the hospital twice a week for 6 weeks. An electrical current of 0-50 amperes with a frequency of 20 herz, and a duration of 200 micro seconds will be applied using 50x50 mm surface electordes. The aim is to create a tingling sensation without causing any pain on the tibial nerve, at the ankle level.
Primary Outcome Measure Information:
Title
Urination frequency
Description
The frequency of urination will be recorded by using a bladder diary. Urination frequency will be questioned before and after the study period.
Time Frame
1 day
Title
Severity of overactive bladder symptoms. Overactive Bladder Questionnaire Validation Study questionnaire
Description
This questionnaire assesses the severity of overactive bladder symptoms in 8 items. Each item is scored from 0 to 5. Higher scores denote worse symptom severity. Maximum score is 40. A score over 11 denotes presence of overactive bladder symptoms. Questionnaire will be answered before and after the treatment period.
Time Frame
1 day
Secondary Outcome Measure Information:
Title
Quality of life. King's quality of life questionnaire
Description
This questionnaire includes a total of 19 questions assessing general quality of life and also questions related to urinary symptoms. Maximum score is 100 and higher scores denote lower levels of quality of life. Questionnaire will be answered before and after the treatment period.
Time Frame
1 day
Title
Level of satisfaction with the treatment. Visual analog scale
Description
After the completion of the study period, patients will be asked to assess their levels of satisfaction with the treatment they received on a visual analog scale.
Time Frame
1 day
Title
Incontinence impact questionnaire-7.
Description
This 7 item questionnaire assesses the impact of urinary incontinence on the patients' daily lives. Maximum score is 100. Higher scores denote worse outcomes. Questionnaire will be answered before and after the treatment period.
Time Frame
1 day

10. Eligibility

Sex
Female
Gender Based
Yes
Gender Eligibility Description
Only biological females will be enrolled in the study.
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Overactive Bladder Questionnaire Validation Study questionnaire 8 scores higher than 11. Post voiding residue levels less than 100 ml. Women aged between 18-70 Exclusion Criteria: Prior history of pelvic surgery Pelvic organ prolapsus of grade 2 or more. Current urinary tract infection
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ece Cinar, MD
Phone
00905372257018
Email
ece.cinar@ege.edu.tr
First Name & Middle Initial & Last Name or Official Title & Degree
Yesim Akkoc, MD
Phone
00902323903690
Email
yesim.akkoc@ege.edu.tr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ece Cinar, MD
Organizational Affiliation
Ege University School of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ege University School of Medicine
City
Bornova
State/Province
Izmir
ZIP/Postal Code
35100
Country
Turkey
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ece Cinar, MD
Phone
005372257018
Email
ece.cinar@ege.edu.tr
First Name & Middle Initial & Last Name & Degree
Yesim Akkoc, MD
Phone
00902323903690
Email
yesim.akkoc@ege.edu.tr
First Name & Middle Initial & Last Name & Degree
Yesim Akkoc, MD
First Name & Middle Initial & Last Name & Degree
Ece Cinar, MD
First Name & Middle Initial & Last Name & Degree
Esra Cansu Selbes, MD
First Name & Middle Initial & Last Name & Degree
Ahmet Ozgur Yeniel, MD
First Name & Middle Initial & Last Name & Degree
Gokay Celtik, MD

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
May be shared when requested
Citations:
PubMed Identifier
27921161
Citation
Bo K, Frawley HC, Haylen BT, Abramov Y, Almeida FG, Berghmans B, Bortolini M, Dumoulin C, Gomes M, McClurg D, Meijlink J, Shelly E, Trabuco E, Walker C, Wells A. An International Urogynecological Association (IUGA)/International Continence Society (ICS) joint report on the terminology for the conservative and nonpharmacological management of female pelvic floor dysfunction. Int Urogynecol J. 2017 Feb;28(2):191-213. doi: 10.1007/s00192-016-3123-4. Epub 2016 Dec 5.
Results Reference
background
PubMed Identifier
30311692
Citation
Ramirez-Garcia I, Blanco-Ratto L, Kauffmann S, Carralero-Martinez A, Sanchez E. Efficacy of transcutaneous stimulation of the posterior tibial nerve compared to percutaneous stimulation in idiopathic overactive bladder syndrome: Randomized control trial. Neurourol Urodyn. 2019 Jan;38(1):261-268. doi: 10.1002/nau.23843. Epub 2018 Oct 12.
Results Reference
background
PubMed Identifier
25623739
Citation
Gormley EA, Lightner DJ, Faraday M, Vasavada SP; American Urological Association; Society of Urodynamics, Female Pelvic Medicine. Diagnosis and treatment of overactive bladder (non-neurogenic) in adults: AUA/SUFU guideline amendment. J Urol. 2015 May;193(5):1572-80. doi: 10.1016/j.juro.2015.01.087. Epub 2015 Jan 23.
Results Reference
background

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Transcutaneous Tibial Nerve Stimulation for Idiopathic Overactive Bladder

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